1077. Tolerability of Central Nervous System Symptoms among HIV-1 Infected Efavirenz Users: Analysis of Patient Electronic Medical Record Data
Session: Poster Abstract Session: HIV: Switching Antiretrovirals
Friday, October 9, 2015
Room: Poster Hall
Posters
  • EFV CNS Sx Tolerability BMS PHAR P4P_FINAL_V2.pdf (2.7 MB)
  • Background: Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus type 1 (HIV-1). There has been concern over EFV tolerability in clinical trials and practice, particularly related to central nervous system (CNS) adverse events. However, observational studies have shown that: 1) 90% of patients remain on EFV-based 1st-line regimens for >1 year (Ford et al., 2015); and 2) CNS-related EFV substitution occurs at a rate of <4 / 100 person-years (Elzi et al., 2010).  We examined the real-world rate of EFV discontinuation due to CNS symptoms in antiretroviral therapy naïve HIV-1 patients.

    Methods: This retrospective cohort study used a large electronic medical records (EMR) database to identify HIV-1 patients >=12 years old and treated with an EFV-based (as part of a fixed dose combination or individual tablet) 1st-line regimen from 1/1/2009 to 6/30/2013. EMR data were from a nationally representative physician panel serving 28 million unique US patients. EFV patients with no prior record of use during the 6-month baseline were classified as new users and were followed for 12 months from medication initiation. EFV discontinuation due to CNS symptoms was defined as evidence of a switch to a replacement antiretroviral agent coupled with an EMR notation of a CNS symptom within 30 days before the switch, absent lab evidence of virologic failure.

    Results: We identified 1742 patients who started EFV as part of a 1st-line regimen. Mean age of patients was 48 years, 22.7% were female, and 8.1% had a prior report of CNS symptoms. In the first year, the overall discontinuation rate among EFV new users was 16%. Ten percent of new users (n=174) had a report of a CNS symptom and 1.1% (n=19) discontinued EFV due to CNS symptoms, specifically insomnia (n=12), headache (n=5), impaired concentration (n=1), and somnolence (n=1). Most CNS symptoms were reported on the date of EFV discontinuation. The frequency of CNS symptoms was similar for patients who discontinued EFV compared to those who did not (10.3 vs. 9.9%; p=0.83).

    Conclusion: Our study found a low rate of EFV discontinuation as a result of CNS adverse events. EFV discontinuation due to CNS symptoms occurred in just over 1% of patients, consistent with prior reports.

    Lisa Rosenblatt, MD, MPH1, Michael S. Broder, MD, MSHS2, Tanya GK Bentley, PhD2, Eunice Chang, PhD2, Sheila Reddy, PhD, RPh2, Elya Papoyan, MPH2 and Joel Myers, MPharm1, (1)Bristol-Myers Squibb, Plainsboro, NJ, (2)Partnership for Health Analytic Research, LLC, Beverly Hills, CA

    Disclosures:

    L. Rosenblatt, Bristol-Myers Squibb: Employee and Shareholder , Salary

    M. S. Broder, Bristol-Myers Squib: Dr. Broder is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research , Dr. Broder is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research

    T. G. Bentley, Bristol-Myers Squib: Dr. Bentley is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research , Dr. Bentley is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research

    E. Chang, Bristol Myers Squib: Dr. Chang is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research , Dr. Chang is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research

    S. Reddy, Bristol-Myers Squib: Dr. Reddy is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research , Dr. Reddy is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research

    E. Papoyan, Bristol-Myers Squib: Ms. Papoyan is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research , Ms. Papoyan is an employee of Partnership for Health Analytic Research, LLC, a health services research company paid by BMS to conduct this research

    J. Myers, Bristol-Myers Squib: Employee and Shareholder , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.